Home NDC 56104-253 Anti- Fungal Miconazole Nitrate
Product NDC 56104-253
11-digit product format 561040253
Labeler code 56104
Product ID 56104-253_3bba5b9f-d184-6f93-e063-6394a90ae951
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form POWDER
Route TOPICAL
Labeler Premier Brands of America Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-11
Marketing end 2027-01-31
Substance MICONAZOLE NITRATE
Active strength 1.42 g/71g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Anti- Fungal Miconazole Nitrate Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 1.42 g/71g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998461 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 56104-253-01 Anti- Fungal Miconazole Nitrate 71 g in 1 BOTTLE, PLASTIC POWDER 71 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56104-253 ANTI- FUNGAL MICONAZOLE NITRATE (MICONAZOLE NITRATE) POWDER [PREMIER BRANDS OF AMERICA INC.] 6 Current NDC, Legacy NDC, 1 package rows 20241016_f186bdc1-db6c-0fab-e053-2995a90a7c58.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 56104-253-01 56104025301 71 g in 1 BOTTLE, PLASTIC (56104-253-01) 71 g 2023-01-05 2027-01-31 No No Current